An interesting question about import company

[Max080]

Hi everyone,

We are a medical device manufacturer based in Suzhou, China, and recently we plan to open a branch office in Shanghai to help us deal with financial and import and export sales issues. Our company products are currently registered in the United States, Europe, Japan, Korea, Brazil, Russia and the United Kingdom. Does our Shanghai branch need to apply for qualification or other applications from the authorities?

Thank you so much for your help,
Max

 

[ChrisM]

"The authorities" in which countries? If you are going to have your products imported into the EU, you will need an EU REP in addition to registering your products on the EUDAMED database. For the UK it is similar (UK Responsible Person), and products need to be registered with the MHRA on their DORS system. I do not know about the other countries that you mention

 

[Max080]

"The authorities" in which countries? If you are going to have your products imported into the EU, you will need an EU REP in addition to registering your products on the EUDAMED database. For the UK it is similar (UK Responsible Person), and products need to be registered with the MHRA on their DORS system. I do not know about the other countries that you mention

Thank you very much for your reply!
Is this only for products? Does our Shanghai subsidiary need to register with EUDAMED?

 

[Raisin picker]

I think this depends on the role your new subsidiary is goint to play. A "helper" is not mentioned in any regulatory document (my knowledge is solely EU here). When they are going to be the legal manufacturer for EU, they need to register here. As long as they only sell to a european importer, there is afaik no need to register (providing the mother is legal manufacturer for EU).
In other words, the EU legislation only recognizes manufacturers outside the union. All others (authorised representative, importer, distributor) have to be EU based to be recognized by EU legislation (MDR).

With other jurisdictions, it may and will be different.

 

[Max080]

I think this depends on the role your new subsidiary is goint to play. A "helper" is not mentioned in any regulatory document (my knowledge is solely EU here). When they are going to be the legal manufacturer for EU, they need to register here. As long as they only sell to a european importer, there is afaik no need to register (providing the mother is legal manufacturer for EU).
In other words, the EU legislation only recognizes manufacturers outside the union. All others (authorised representative, importer, distributor) have to be EU based to be recognized by EU legislation (MDR).

With other jurisdictions, it may and will be different.

Thank k you very much for your reply. When I checked the regulations of the European Union, I found that there was no definition of "helper" in the regulations. I was also confused whether we should input this company into the system of EUDAMED..

 

[ChrisM]

You as manufacturer will need to register with EUDAMED as a manufacturer. Your EU REP will also have to be registered with EUDAMED as a representative. Your importing company will have to be based in the EU and I believe will also have to be registered with EUDAMED. You may find one organisation that can act as importer and EU REP. Different rules apply for the UK.

For european sales, your products also have to be registered with EUDAMED. For the UK, similar rules apply but with reference to the MHRA. It suggests that your company needs to have a Regulatory Affairs Specialist, either as an employee or as a consultant with a suitable agreement in place. Medical device regulation and registration in Europe and the UK is not straightforward; you may consider it better to avoid selling there because of the costs, timescales and bureaucracy involved.